Food products containing omega-3 fatty acids

ABSTRACT

The present invention relates to food products having a high omega-3 fatty acid content, as well as methods of preparing those food products.

RELATED APPLICATION

This application claims priority to U.S. Provisional application No.61/028,028, Attorney Docket No. AIJ-008-1, filed Feb. 12, 2008, entitled“FOOD PRODUCTS CONTAINING OMEGA-3 FATTY ACIDS.” The contents of anypatents, patent applications, and references cited throughout thisspecification are hereby incorporated by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates to food products having a high omega-3fatty acid content, which are capable of being cooked withoutsubstantial separation of the omega-3 fatty acid, as well as methods ofpreparing those food products. The products can have a variety offlavors, and serve as a vehicle for the delivery of a number ofnutritious and therapeutic ingredients.

BACKGROUND OF THE INVENTION

The human body is capable of producing most of the saturated fatty acidsthat it requires. Certain polyunsaturated, omega-3 fatty acids, however,cannot be synthesized and must be supplied through diet. For thisreason, these fatty acids are referred to as essential fatty acids.Certain foods, such as fish oil, provide the essential fatty acids, andhave the advantage of directly offering a consumer eicosapentaenoic acid(EPA) and docosahexaenoic acid (DHA), thereby bypassing the ofteninefficient biochemical synthesis of these compounds from alphalinolenic acid (ALA).

Research has shown that these fatty acids reduce the risk of heartdisease, and have a positive effect on children's development when takenat sufficient amounts. Results have also been published indicating thatthese fatty acids have a positive effect on certain mental illnesses,autoimmune diseases, joint complaints, and weight control. There are,therefore, many reasons for taking dietary supplements containingomega-3 fatty acid sources, such as fish oil. However, many peopleconsider the taste and texture of these oils to be unpleasant.Furthermore, oils high in omega-3 fatty acid are susceptible tooxidation, which results in reduced health benefits and increasedunpleasant odor and taste. Food manufacturers have added omega-3 fattyacids to food products, thereby concealing their unpleasant taste.However, because omega-3 fatty acids separate out of food products whenadded in high amounts and/or easily oxidize, most products containamounts that are far below the required health-benefiting dose of atleast 750 mg EPA/ DHA per day.

Thus, there remains a need for food products that contain high amounts(e.g., 750-4000 mg) of omega-3 fatty acid(s) per serving, as well as amanufacturing process for producing such food products.

SUMMARY OF THE INVENTION

The present invention provides food products, particularly those thatare cooked or capable of being cooked, containing high concentrations ofomega-3 fatty acids (e.g., 750-4000 mg of ALA, DPA, EPA and/or DHA perserving), without substantial separation or oxidation of the fattyacids. The food products also have the advantage of being free from theunpleasant taste and odor of the omega-3 fatty acids. Furthermore, theseproducts have a high dietary fiber content and a low glycemic index, andcan serve as a vehicle for other beneficial vitamins, minerals,nutrients and therapeutics. The products can have a variety of flavors,and serve as a vehicle for the delivery of minerals, vitamins,supplements or medications.

Accordingly, in one aspect, the invention provides a method of producinga homogenous food product having a high omega-3 fatty acid content,wherein the food product is capable of being cooked without substantialseparation or oxidation of the omega-3 fatty acid. The method comprisescombining a fruit juice concentrate or vegetable juice concentrate withan oil containing an omega-3 fatty acid, preferably in unencapsulatedform, to form a liquid mixture, wherein the ratio of oil to concentratedjuice is approximately 0.5:4-2:1, e.g., approximately 1:2, by weight;and combining the liquid mixture with a fiber agent to form a solid,edible food product. In a particular embodiment, the ratio of liquidmixture to fiber agent is about 1:2, by weight. In another embodiment,the ratio of oil to concentrated juice is approximately 0.5:4-2:1, e.g.,approximately 1:2, by weight. In still another embodiment of the method,the oil comprises approximately 4-20%, e.g., 10-20%, by weight, of thetotal solid food product.

Suitable fruit juice concentrates that can be employed in the inventioninclude, but are not limited to, concentrated orange juice, concentratedgrapefruit juice, concentrated pineapple juice and concentratedcranberry juice. Suitable fruit juice concentrates that can be employedin the invention also include, but are not limited to, concentrated nonijuice, concentrated acai juice, concentrated goji juice, concentratedblueberry juice, concentrated blackberry juice, and concentratedraspberry juice. Suitable vegetable juice concentrates that can beemployed in the invention include, but are not limited to, concentratedbeet, concentrated tomato, or concentrated carrot juice.

Suitable omega-3 containing oils that can be employed in the inventioninclude, but are not limited to, fish oils such as cod liver oil, fishbody oil, krill derived oil, anchovy oil, shark liver oil or seal oil,as well as vegetable oils. The oil can also be an algae oil. In oneembodiment, the oil that is used to produce the homogenous food producthaving a high omega-3 fatty acid content contains at least 10%, e.g., atleast 30%, omega-3 fatty acid. The oil may also contain EPA and/or DHA.When the oil contains both EPA and DHA, these omega-3 fatty acids canexist in a ratio of about 1:6-6:1, e.g., 1:1-2:3 (EPA:DHA). In apreferred embodiment, the oil is not encapsulated.

Suitable fiber binding agents for use in the invention include, but arenot limited to, grains selected from the group consisting of crackedwheat, multi-grain, flour, oats, oat bran, oatmeal, pumpernickel, rye,seven bran, twelve bran, seven grain, nine grain, stoned wheat, wholewheat, wheat berry, whole bran, millet, maze, quinoa, rice pectin, fruitpeal, and fruit seeds and combinations thereof.

The manufacturing method of the invention can further include the stepof adding additional ingredients to improve consistency, stabilityand/or taste of the food product. Such additional ingredients include,for example, water, sugar (and/or other natural sweeteners), bakingpowder, baking soda, salt, eggs, egg whites, nuts and fruit. Theingredients also include spices, such as cinnamon, ginger, cloves, andnutmeg, and proteins like whey and other anti-oxidants.

Other health-benefiting ingredients also can be added to the foodproduce of the invention, such as water-soluble and/or oil-solubledietary supplements and/or medicaments. These include, for example,cholesterol lowering drugs, antihypertensive drugs, anti-inflammationdrugs, pain killers, hormones, antibiotics, antidepressants,antiepileptics, neuroleptics, neurostimulants, libido stimulant drugs,erectile dysfunction drugs, chemotherapy agents, diabetes medication,HIV medication, hair loss medication, weight loss medications, omega-6derivatives, omega-9 derivates, antioxidants, vitamins, and minerals.

Food products made according to the invention have the advantage ofbeing amenable to being cooked (e.g., baked), without substantialseparation or oxidation of the omega-3 fatty acids. Accordingly, in oneembodiment, the method further includes the step of cooking the foodproduct. Suitable forms of cooking include, for example, baking, frying,microwaving, grilling and/or any other form of heating.

Food products produced by way of the above-described methods can be in avariety of forms including, but not limited to cookies, muffins, cakes,bread, rolls, biscuits, candies, ice creams, and cereals.

In another aspect, the invention provides a manufactured food productcomprising about 750-4000 mg of non-encapsulated omega-3 fatty acid perabout 50-150 g serving size. In one embodiment, the serving size of themanufactured food product is about 60-100 g, e.g., about 70 g or 80 g.In another embodiment, the manufactured food product is in the form of acookie. The manufactured food product can further comprise concentratedorange juice, concentrated pineapple juice, concentrated grapefruitjuice, concentrated cranberry juice, or concentrated grape juice. Themanufactured food product can further comprise concentrated vegetablejuice, such as concentrated beet, concentrated tomato, or concentratedcarrot juice. The omega-3 fatty acid source for the manufactured foodproduct can be a fish oil (e.g., cod liver oil, fish body oil, or hillderived oil) or vegetable oil. The oil can contain EPA and/or DHA, or atleast 10% omega-3 fatty acid.

In another aspect, the invention provides a manufactured, bite-sizedfood product comprising about 150-800 mg of non-encapsulated omega-3fatty acid per about 15-20 g serving size. This bite-sized product cancontain any of the ingredients discussed herein, and can take the formof a cookie.

The manufactured food product can comprise a fiber binding agent,wherein the fiber binding agent comprises a grain selected from thegroup consisting of cracked wheat, multi-grain, flour, oats, oat bran,oatmeal, pumpernickel, rye, seven bran, twelve bran, seven grain, ninegrain, stoned wheat, whole wheat, wheat berry, whole bran, rice, millet,quinoa, maze, barley, fruit seed flour, and fruit peal flour andcombinations thereof. The food product can also comprise sugar, bakingpowder, baking soda, salt, eggs, egg whites, nuts or fruit. The foodproduct can also comprise spices, such as cinnamon, ginger, cloves, andnutmeg, and proteins like whey and other anti-oxidants. In oneembodiment, the manufactured food product additionally includes awater-soluble or oil-soluble medicament or diet supplement, such ascholesterol lowering drugs, antihypertensive drugs, anti-inflammationdrugs, pain killers, hormones, anti-depressants, weight lossmedications, antioxidants, vitamins, minerals (e.g., calcium and/ormagnesium), glucosamine, CoQ-10, and/or green tea.

In another aspect, the invention provides a manufactured food productcomprising concentrated fruit juice, non-encapsulated fish oil, sugar,oats, flour, baking soda, baking powder, salt, calcium citrate powder,cinnamon, vanilla extract, and egg whites, and the food product hasabout 750-4000 mg of omega-3 fatty acid per about 50-150 g serving. Inanother aspect, the invention provides a manufactured food productcomprising oats, whole wheat, baking soda, baking powder, cinnamon,powdered ginger, powdered cloves, calcium citrate, orange peel fiber,xanthan gum, fish oil, concentrated fruit juice, egg white, fruitflavored water, and liquid vitamin D, and the food product has about750-4000 mg of omega-3 fatty acid per about 50-150 g serving. In oneembodiment of these manufactured food products, the manufactured foodproducts are in the form of a cookie.

DETAILED DESCRIPTION OF THE INVENTION

The lack of health-benefiting vitamins and nutrients such as essentialfatty acids, dietary fiber, calcium, and vitamin D in the typicalwestern diet has lead to a number of health problems, including obesity,chronic inflammation, heart diseases and mental diseases. Moreover, itis estimated that Americans have only half the amount of omega-3 intheir cells compared to the Japanese, who, on average, have the greatestlife-spans in the world. In addition, the high EPA/DHA intake in theJapanese culture may explain the low rate of arteriosclerosis in Japan.It is virtually impossible for Americans to reach omega-3 levels foundin Japanese societies with a diet of fish alone, because most people arediscouraged from ingesting large amounts of fatty fish due to a risk ofheavy metal contamination. Thus, there are many reasons for takingdietary supplements containing purified omega-3 fatty acid sources, suchas fish oil, to increase levels of EPA/DHA in the cell. However, manypeople consider the taste or after taste of these oils to be unpleasant,and will resist taking them or using them in adequate amounts, despitestrong recommendation from health authorities.

Research has also shown that diets high in dietary fibers, andespecially soluble fibers, may have equally positive health effects,such as a reduction in heart disease, certain digestive cancers andweight. It is estimated that most Westerners only ingest half of therecommended daily amount of fiber, which may be due to increasedconsumption of highly processed foods that contain limited amounts offiber. Research indicates that low glycemic (a value relating to howfast and how high a post prandial glucose response will be) foodscontaining fibers and carbohydrates from whole grains and certainvegetables and fruits may increase satiety (and thereby weight control)and mental focus, and facilitate blood sugar control in subjects withmetabolic disorders, such as diabetics or pre-diabetics

Furthermore, adding oil to carbohydrates tends to lower the glycemicresponse to a meal. Also, dietary fibers and omega-3 fatty acids havemany of the same health benefits, but are effective through differentmodes of action, which opens the possibilities of synergistic andaugmented health effects when these nutrients are combined.

While food products fortified with omega-3 fatty acids are currentlyavailable to the public, a typical serving size of these productsgenerally provides meager amounts of these essential compounds. Forexample, one 8-oz. glass of Horizon Organic® Milk Plus DHA contains 32mg of DHA, which is only a fraction of the recommended daily dose ofthis essential fatty acid. “Mr. Cookie” (http://www.goodfoods.ca)provides only 25 mg of DHA per 65 g serving of cookie. Moreover, theomega-3 fatty acids are typically in micro-encapsulated form to preventtheir separation during production, storage and/or cooking of the foodproduct. Accordingly, the present invention provides food products, andmethods of making food products, that have a high omega-3 fatty acidcontent of at least about 50 g, e.g., 750-4000 mg, of omega-3 fatty acidper serving (e.g., 70 g or 80 g total weight). In addition, the foodproducts include a significant amount of nutritional fibers and lowglycemic index carbohydrates.

Definitions

As used herein, the term “concentrated fruit juice” and “concentratedvegetable juice” refers to fruit or vegetable juice from which a portionof the water has been removed. Processes for preparing concentratedfruit and vegetable juice are known in the art (see, e.g., Richard F.Matthews “Frozen Concentrated Orange Juice From Florida Oranges” FactSheet FS 8, a series of the Food Science and Human Nutrition, FloridaCooperative Extension Service, Institute of Food and AgriculturalSciences, University of Florida. April 1994, which is incorporatedherein by reference in its entirety). The concentrated fruit orvegetable juice can include pulp fibers. As used herein, the term “pulpfibers” refers to that portion of a fruit or vegetable which remains inthe juice after removal of the juice from the fruit or vegetable andtypically includes various ratios of cellulose, mucilage, hemicellulose,lignin, pectic material (pectin), and other water insoluble materials.Suitable fruit juice concentrates that can be employed in the inventioninclude, but are not limited to, concentrated orange juice, concentratedpine apple juice, concentrated grapefruit juice, concentrated cranberryjuice, concentrated noni juice, concentrated acai juice, concentratedgoji juice, concentrated blueberry juice, concentrated blackberry juice,and concentrated raspberry juice. Suitable vegetable juice concentratesthat can be employed in the invention include, but are not limited to,concentrated carrot, concentrated beet or concentrated tomato juice.

The term “cooking” refers generally to the application of heat to foodproducts in a domestic or industrial context and includes any form ofheating, such as baking.

The term “cookie” as used herein is intended to include any bakedproduct being similar to a cookie no matter what shape or form. Forconvenience, the invention will be described with reference to cookies,but it is to be understood that the term “cookie” as used herein isintended to generically cover the broad class of baked products such ascookies, biscuits, and similar baked products.

The term “homogenous” refers to an omega-3 fatty acid containing foodproduct that does not exhibit substantial separation of the omega-3fatty acid, even in the absence of encapsulation of the omega-3 fattyacid.

The term “serving” or “serving size” as used herein refers to FDAregulation 21 CFR 101.9(b) and 21 CFR 101.12 (herein incorporated byreference). The serving size typically appears on food labels and isbased on FDA-established lists of “Reference Amounts CustomarilyConsumed Per Eating Occasion,” which in most cases reflect the foodquantities set forth in 21 CFR 101.12. Examples of serving sizes of thefood products of the invention include, but are not limited to,approximately 5 g-150 g, e.g., 7 g-120 g, e.g., 10 g-90 g, e.g., 20 g-80g, e.g., 30 g-70 g, e.g., 40 g-65 g, e.g., about 45-60 g. In oneembodiment, the serving size is approximately 60-100 g, e.g.,approximately 70 g or 80 g.

Similarly, the term “recommended daily dose” refers to the amount ofrecommended servings of a nutritional supplement (e.g., an omega-3 fattyacid, e.g., EPA, DPA, DHA and/or ALA).

The term “bite-sized” refers to a food product of a size that can beeaten in one bite, e.g., 15-20 g.

The term “manufactured food product” as used herein refers to a foodproduct produced by combining two or more components, such that the foodproduct does not exist in nature. Accordingly, manufactured foodproducts of the present invention have undergone processing (e.g.,mixing, kneading, stirring, whisking, cutting, chopping, mincing,pounding, pulverizing, macerating, milling, grinding, and/or, cooking,etc.).

The term “subject” refers to mammalian subjects, e.g., humans, dogs,cows, horses, pigs, sheep, goats, cats, mice, rabbits, and rats, thatare capable of benefiting from omega-3 fatty acids.

The term “treat,” “treated,” “treating” or “treatment” includes thediminishment or alleviation of at least one symptom of a disease uponconsuming the omega-3 fatty acid-containing food product of theinvention. Treatment can be diminishment of one or several symptoms of adisorder or complete cure of a disorder.

The term “prevent” or “prevention” refers to reducing or abolishing therisk that some undesired health condition or disease may occur.

The term “combining” refers to the process whereby compounds are broughtinto a close relationship to result in a mixture in which eachindividual ingredient is present. Combining of ingredients (e.g., afruit/vegetable juice concentrate, an oil containing an omega-3 fattyacid, and a fiber binding agent) can be done with any suitable mixingtechnique, including stiffing, whisking, pounding, pulverizing,macerating, milling, grinding, tumbling, etc.

Food Products Containing Omega-3 Fatty Acids

In one embodiment, the invention provides a method of producing a foodproduct having an omega-3 fatty acid content, comprising combining afruit juice concentrate or vegetable juice concentrate with an oilcontaining an omega-3 fatty acid to form a homogenous liquid mixture;and combining the liquid mixture with a fiber binding agent to form anedible food product. The method of the present invention is advantageousbecause it produces a food product that is homogenous, and contains highdosages of omega-3 fatty acids and dietary fibers without substantialseparation of the omega-3 fatty acid from the food product, as well aslittle or no unpleasant taste associated with high dosages of omega-3fatty acids per each serving unit. In a particular embodiment, themethods of the invention produce a food product that has a high omega-3fatty acid content of at least about the recommended daily dose of 750mg-4000 mg of omega-3 fatty acids. (See, e.g., Covington, AmericanFamily Physician, Vol. 70, No. 1, pp. 133-140, which is incorporatedherein by reference in its entirety). The high omega-3 fatty acidcontent can be supplied by EPA, DHA or a combination thereof.

The omega-3 fatty acid component can be any fatty acid that includes adouble bond at the third carbon from the omega position of the fattyacid. Omega-3 fatty acids suitable for the invention include EPA, DHA,docosapentaenoic acid (DPA) and/or alpha linolenic acid (ALA). The foodproduct of the invention can contain one or more of these omega-3 fattyacids, e.g., EPA and DHA, in a variety of different ratios. For example,the omega-3 fatty acid component of the food product can include a ratioof EPA to DHA of about 1:6-6:1; or 10:1, 5:1, 2:1, 1:1, 1:2, 1:5 or1:10; or 1:1-2:3 by volume, per serving of food product. In a particularembodiment, the omega-3 fatty acid is not encapsulated. In oneembodiment of the method, the oil comprises approximately 5-20%, e.g.,10-20%, by weight, of the total solid food product. As used herein, theterm “omega-3 fatty acid” can refer to either the omega-3 fatty aciditself (EPA, DHA, etc.), or, as described below an omega-3 fatty acidsource (e.g., fish oil).

Any suitable source of omega-3 fatty acid can be used in the invention,including, but not limited to vegetable oils, marine oils such as fishoils and fish liver oils, and algae. Possible vegetable oil sourcesinclude olive oil, soybean oil, canola oil, high oleic sunflower seedoil, high oleic safflower oil, safflower oil, sunflower seed oil,flaxseed (linseed) oil, corn oil, cottonseed oil, peanut oil, eveningprimrose oil, borage oil, and blackcurrant oil. Suitable fish oilsinclude cod liver oil, fish body oil, or krill derived oil. Othersources include salmon oil, cod oil, herring oil, mackerel oil, anchovyoil, anchovies, sardine oil, menhaden oil or shark liver oil. In oneembodiment, the method of the invention uses an oil that contains atleast 10%, e.g., at least 30%, omega-3 fatty acid. In a particularembodiment, the omega-3 fatty acid source is not encapsulated.

The methods of the invention further include the use of fruit juice orvegetable juice concentrate, which, when mixed with the omega-3 fattyacid source (e.g., fish oil), assists in suppressing the smell and/ortaste of the oil in the food product. By suppressing the smell and/ortaste of the omega-3 fatty acid, or the omega-3 fatty acid source (e.g.,fish oil), one can load a higher concentration of the omega-3 fatty acidinto a single serving of a food product without the consumer of the foodproduct detecting the presence (i.e., smell and/or taste) of the omega-3fatty acid in the food product.

Furthermore, by combining the omega-3 fatty acid with a fruit juice orvegetable juice concentrate, one can load a higher concentration of theomega-3 fatty acid into a single serving of a food product, withoutsubstantial separation of the omega-3 fatty acid from the food product

The food products of the instant invention are also advantageousbecause, in addition to having a high content of omega-3 fatty acid,they also serve as a good source of dietary fiber. Dietary fiber isusually divided according to whether it is water-soluble or not. Bothtypes of fiber are present in all plant foods, with varying degrees ofeach according to a plant's characteristics. Insoluble fiber possessespassive water-attracting properties that help to increase bulk, softenstool and shorten transit time through the intestinal tract. Solublefiber undergoes metabolic processing via fermentation, yieldingend-products with broad, significant health effects. For example, theskin of a plum is an example of an insoluble fiber source, whereassoluble fiber sources are in the pulp in the inside of the fruit. Othersources of insoluble fiber include whole wheat, wheat and corn bran,flax seed, lignans and vegetables such as celery, nopal, green beans,potato skins and tomato peel. Known sources of soluble fibers are peas,beans, oats, apples and carrots. Soluble fibers have been shown todecrease the cholesterol and lipid levels of those who consume them.

While not wishing to be bound by theory, it is believed that that thefruit juice or vegetable juice concentrate, when combined with the oilyomega-3 fatty acid component (e.g., fish oil) forms an emulsion. Inturn, this emulsion, when combined with fiber binding agent, results ina homogenous food product with an amount of omega-3 fatty acid thatwould not have been achieved without substantial separation of the oilyomega-3 fatty acid. The emulsion may form due to the interaction of theomega-3 fatty acid with the high content of fibers (e.g., pectin) thatremain in the concentrated fruit juice or concentrated vegetable juice.This is possibly due to the fibers (e.g., pectin) binding to the omega-3fatty acids, thereby facilitating the formation of an emulsion. Withoutwishing to be bound by theory, by binding to the omega-3 fatty acids,the fibers from the concentrated fruit or vegetable juice interact withthe omega-3 molecules and impede oxidation of the fatty acids, therebypreventing the degradation of the fatty acids in the food product.Accordingly, in one embodiment of the invention, pectin can be added tothe mixture of omega-3 oil and concentrated fruit or vegetable juice tofacilitate the formation of an emulsion.

The emulsion also can be mixed with a variety of additional ingredients(described herein), including oil or water soluble therapeutic agentsand will not separate from those ingredients. As such, the emulsion,when combined with a fiber binding agent, results in, or, alternatively,can be used as an ingredient in, a food product that has a “high”omega-3 fatty acid content, meaning it can provide a subject with arecommended daily dose of essential omega-3 fatty acids in one serving.

Concentrated fruit juices that can be used in the food product of theinvention include, but are not limited to, concentrated orange juice,concentrated grapefruit juice, concentrated pineapple juice,concentrated cranberry juice, or concentrated grape juice. In anotherembodiment, the concentrated juice can be concentrated banana juice,concentrated apple juice, concentrated pear juice, concentratedpomegranate juice, concentrated carrot juice or concentrated tomatojuice. In one embodiment, the concentrated fruit or vegetable juice canbe fortified, e.g., fortified orange juice. The proportion of theomega-3 fatty acid (e.g., omega-3 fatty acid source, e.g., oil) toconcentrated fruit or vegetable juice is preferably approximately0.5:4-2:1, e.g., approximately 1:2, by weight.

The present invention further includes the use of a fiber binding agent,which refers to any fiber source that can be added to the omega-3 fattyacid/concentrated fruit or vegetable juice composition to produce asolid, edible food product. The beneficial effects of combining fish oilwith a fiber source (e.g., bran) are known in the art. For example, thecombination of bran with fish oil offers considerable benefit in themanagement of hyperlipidemia (see, e.g., Topping et al., Journal ofNutrition, Vol. 120 No. 4, pp. 325-330, incorporated herein by referencein its entirety). The fiber binding agent also offers the advantages ofbinding the fish oil during the upper digestion period, thus providingboth physiologically needed nutrients, roughage, and reduced risk ofnausea often related to taking fish oil without food. Examples ofsuitable fiber binding agents include, but are not limited to, crackedwheat, multi-grain, flour, oats, oat bran, oatmeal, pumpernickel, rye,seven bran, twelve bran, seven grain, nine grain, stoned wheat, wholewheat, wheat berry, whole bran, millet, maze, quinoa, rice pectin, fruitpeal, and fruit seeds and combinations thereof. Exemplary fiber bindingagents include oats and whole wheat. The ratio of the omega-3 fattyacid/concentrated fruit/vegetable juice composition to the fiber bindingagent is preferably approximately, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3,1:4 or 1:5, by weight. In a particular embodiment, the ratio is about1:2, by weight.

Once the omega-3 -containing food product of the invention is prepared,it can be mixed (using known techniques) with additional foodingredients to improve taste, consistency and/or the ability to becooked (e.g., baked). Such ingredients include, but are not limited to,water, sugar or other natural sweeteners, baking powder, baking soda,salt, eggs, egg whites, nuts or fruit. In one embodiment, the fruit israisins, cranberries, blueberries, raspberries, papaya, pineapple, driedapples, bananas, ginger, dates, figs, orange peel, lemon peel and/orlime peel. In another embodiment, the nuts are hazel nuts, pecan nuts,walnuts, and/or butternuts. The food product can also include acombination of fruits and nuts. The ingredients also include spices,such as cinnamon, ginger, cloves, nutmeg and proteins like whey andother anti-oxidants. The ingredient can also include xanthan gum. Thoseskilled in the art will recognize, or be able to ascertain using no morethan routine experimentation, many equivalent ingredients that can beused in combination with the omega-3-containing food product of theinvention.

Other ingredients that may be included in the food product of theinvention include, but are not limited to, enriched flour, white sugar,brown sugar, margarine, non-hydrogenated margarine, canola oil,non-hydrogenated canola oil, modified palm oil, palm oil, palm kerneloils, water, salt, milk, modified milk ingredients, soya lecithin,potassium sorbate, artificial flavoring, sugar, chocolate, chocolateliquor, cocoa butter, dextrose, soy lecithin, corn syrup, eggs, sodiumbicarbonate, and baking powder. Alcoholic beverages, such as wine, canalso be included in the food product as an ingredient.

Omega-3-containing food products of the invention additionally caninclude other oil and/or water soluble therapeutic agents. Because thefood product is formed by an emulsion of an oily omega-3 fatty acidsource and a hydrophilic fruit or vegetable juice, the additionaltherapeutic agents can be water-soluble or oil-soluble, includingwater-soluble or oil-soluble diet supplements or medicaments, including,but not limited to, antioxidants, cholesterol lowering drugs,antihypertensive drugs, anti-inflammation drugs, pain killers, hormones,anti-depressants, and/or weight loss medications.

Omega-3-containing food products of the invention also can containminerals, such as calcium, magnesium, manganese, zinc, magnesium, iron,and phosphorus; and/or vitamins such as Vitamin A, the Vitamin B group,Vitamin C, D, E and K.

Omega-3-containing food products of the invention can be processed usingany known technique (e.g., mixing, blending, kneading) to form an ediblefood containing the omega-3-containing food product. The food productalso can be further processed by cooking (e.g., heating, baking,toasting, etc.). The result is a homogenous, edible omega-3-containingfood product containing at least about 750 mg-4000 mg of omega-3 fattyacids per serving, without separation (or encapsulation) of the omega-3fatty acid or unpleasant taste or odor. In one embodiment, the ediblefood comprises more than about 50 mg, more than about 500 mg, or about1000-4000 mg of EPA, DHA, ALA, or DPA, individually or in somecombination, per serving of foodstuff.

Edible food products of the invention include, but are not limited to,baked goods, pastas, condiments, soup mixes, snack foods, nut products,hard candies, soft candies, sauces, gravies, syrups, nutritional bars,cookies, jams or jellies, pet foods, bread, tortillas, cereal, icecream, yogurt, milk, salad dressing, rice bran, crackers, muffins, orcakes. In a particular embodiment, the edible food is a cookie. Inanother embodiment, the edible food as a bread or “wrap” that employs atomato paste in substitution for the concentrated juice. Thus, alsoprovided herein is a manufactured food product comprisingnon-encapsulated omega-3 fatty acid and tomato paste.

Methods of Treatment Using Food Products Containing Omega-3 Fatty Acids

Due to the known beneficial effects of omega-3 fatty acids, and theability to include other nutrients or therapeutic agents, omega-3containing food products of the invention can be used to treat orprevent a wide variety of diseases and disorders.

Accordingly, the food products of the instant invention can be used, forexample to prevent or reduce the risk of coronary heart disease, treatcertain circulatory problems, such as varicose veins, stimulate bloodcirculation, stimulate the breakdown of fibrin, lower blood pressure,reduce blood triglyceride levels, reduce secondary and primary heartattack, treat rheumatoid arthritis, cardiac arrhythmias, depression,thrombosis and anxiety, as well as reduce the risk of ischemic andthrombotic stroke. The food products of the instant invention also canbe used for the treatment of cancer or cancer prevention, such asbreast, colon and prostate cancer. The food products of the inventioncan also be used to control the blood sugar of a subject with ametabolic disorder, e.g., diabetes, or prevent the passage frompre-diabetic stages to full diabetes.

In one embodiment, the omega-3 containing food products of the inventionare used to treat autism, ADD, pre-dementia, depression, schizophrenia,epilepsy, macular degeneration, glaucoma, arthritis, weight control,weight loss, hair loss (alopecia) hypertension, dyslipidemia, diabetes,cognitive effects, Parkinson's disease, asthenia, sexual dysfunction,skin burns, infertility and HIV. In another embodiment, the omega-3containing food products are used to reduce triglycerides in a subject.In still another embodiment, the omega-3 containing food products areused to reduce wrinkles in a subject. In yet another embodiment, theomega-3 containing food products can be used as an adjuvant to a cancertherapy.

In still another embodiment, the omega-3 containing food products can beused to improve weight control, weight loss, and cognitive functioningin a subject. In another embodiment, the omega-3 containing foodproducts are used to reduce the plasma lipid profile of a subject.

In particular embodiments, the omega-3-containing food product containsadditional therapeutic agents. Depending on the type of medicaments thatare included in the food product (e.g., cholesterol lowering drugs suchas statins, antihypertensive drugs, anti-inflammation drugs, painkillers, hormones, anti-depressants, medications to treat migraine,and/or weight loss medications), the food product can be used to treatany number of diseases and disorders in a subject.

Kits

Advantageously, the present invention also provides kits (e.g.,pre-packaged mixes) for preparing the omega-3 containing food productsof the invention. Omega-3 fatty acids are prone to oxidation/loss ofeffect by time, high temperature, light, and poor storage conditions.Thus, one advantage of such a kit is the ability to ship the pre-mixedingredients of the invention to the consumer (e.g., a baker), so theconsumer can produce a fresh food product containing a precise andpredetermined high-dose of omega-3 fatty acids and fiber.

Kits of the invention comprise, at least in part, a) a fruit orvegetable juice concentrate with an oil containing an omega-3 fattyacid, and a fiber binding agent as described herein; and, optionally, b)instructions for preparing the omega-3 containing food products of theinvention (e.g., a cookie having a high dose of an omega-3 fatty acid).For example, the instructions can include baking instructions, includinghow to blend the ingredients of the invention, how to measure theingredients, proper baking temperature, proper baking times, packagingprocedures, and storage requirements.

The kit can further include the additional food and/or nutritionalingredients described herein, including, but not limited to, sugar orother natural sweetener, baking powder, baking soda, salt, eggs, eggwhites, nuts or fruit, as well as a water-soluble or oil-soluble dietsupplement or medicament.

The kit as used in the instant application includes a container forcontaining the separate ingredients of the invention (e.g., a fruit orvegetable juice concentrate with an oil containing an omega-3 fattyacid, and a fiber binding agent, or some combination thereof), such as adivided container. The container can be in any conventional shape orform as known in the art which is made of an acceptable material, forexample, a paper or cardboard box, a glass or plastic bottle or jar, ora re-sealable bag, such as a food-grade plastic bag. Furthermore, thekit can include one or more empty food-grade plastic bags with an FDAcompliant label that can be used to carry the baked food product of theinvention.

Equivalents

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the invention described herein. Such equivalents areintended to be encompassed by the following claims.

Incorporation by Reference

The entire contents of all patents, published patent applications,websites, and other references cited herein are hereby expresslyincorporated herein in their entireties by reference.

Exemplification

The invention is further illustrated by the following example. Theexample should not be construed as further limiting.

General Preparation of Food Product with High Omega-3 Fatty Acid Content

Fish oil (flavored or unflavored) is mixed with, preferably, frozenconcentrated fruit or vegetable juice, e.g., orange juice, to form anemulsion with the oil. Optionally, pectin can be added to facilitatepreparation of the emulsion. The emulsion is preferably kept cool orfrozen, and separate from the dry baking ingredients until baking.

Exemplary cookie with High Omega-3 Fatty Acid Content: Recipe 1

150 g dark brown sugar

365 g old fashioned rolled oats

370 g whole wheat flour

12 g baking soda

2 g baking powder

5 g salt

40 g Ca citrate powder

2.5 g ground cinnamon

200 g dried cranberries

85 g chopped walnuts

7 g vanilla extract

270 g egg whites

260 g frozen, concentrated orange juice

145 g Omega Cure omega-3 fish oil (http://www.omega-cure.com/)

7 g vanilla extract

The above ingredients are mixed, and then formed into round cookieshapes. The resulting cookie mixture is baked at 350° F. for 14 minutes,or alternatively 325° F. for 15 minutes, and then placed in the freezerafter cooling to room temperature. This results in about 25 cookiesweighing about 80 g each, containing 1000 mg EPA/DHA each or 2700 mgtotal omega-3 fatty acids (EPA/DPA/DHA).

Exemplary Cookie with High Omega-3 Fatty Acid Content: Recipe 2 (Nosugar added)

790 g oats

530 g whole wheat

12 g baking soda

12 g baking powder

16 g cinnamon

10 g powdered ginger

10 g powdered cloves

80 g calcium citrate

50 g orange peel fiber

4 g xanthan gum

350 g fish oil with 30% concentration EPA/DHA

650 g concentrated orange juice

300 g egg white

400 g cranberry flavored water

80000 iu injection of liquid vitamin D (40 ml by syringe)

500 g cranberries (or tropical fruits or chocolate chips)

The above ingredients are mixed, and then formed into round cookieshapes. The resulting cookie mixture is baked at 325° F. for 15 minutes,and then placed in the freezer after cooling to room temperature. Thisresults in about 44 cookies weighing about 70 g each, containing 2300 mgEPA/DHA and 2 grams soluble dietary fibers. each or 2700 mg totalomega-3 fatty acids (EPA/DPA/DHA). These cookies had a shelf life inroom temperature of approximately 2-3 weeks, and a peroxide value(oxidation) below 10. These no-sugar cookies would be appealing forsubjects with a metabolic disorder (such as type 2 diabetes), or anysubject that could benefit from a low sugar, low Glycemic index food.

Human Studies Using an Exemplary Cookie with High Omega-3 Fatty AcidContent

Thirty seven humans were asked to participate in a trial study, eating 1cookie (as described in recipe 1) every morning, every day for 6 weeks.The participants typically consumed little fish or omega-3 supplements.

At the beginning of the study a nurse drew blood and weighed theparticipants. The blood was sent to a lab to measure triglycerides,total cholesterol, HdL, LdL and blood sugar. A sub sample of blood wassent to a research center to measure the omega-3 index, which is anumber that reflects the amount of omega-3 EPA/DHA incorporated into redblood cell membranes. The same procedures were repeated after 6 weeks,

Every morning the participants were given a cookie containing a highdose of omega-3 fatty acid, and the cookie was eaten. Every Friday eachparticipant got 2 extra cookies to eat at home during the weekend.Throughout the study the participants were asked to on comment cookietexture and taste.

The omega-3 content in the cells of the participants increased by 100%in 6 weeks. The participants also saw a reduction in triglycerides andcholesterol risk profile (10% improvement of the HdL/LdL ratio, which istypically not seen using omega-3 alone), and the participants reportedincreased satiety and less snacking. The participants did not notice anyfishy taste or smell and the compliance to eating the cookie every daywas exceptionally high (95%), showing that the invention has solved theresistance of the general consumer to fish oil products.

A laboratory also measured the fatty acid profile of the cookie, theshelf life with respect to yeast, mold and bacteria growth and peroxidelevels, in addition to full nutritional fact labeling and fiber profile.The tests and studies confirmed that the omega-3 had not been diminishedor oxidized by the food preparation and that the clinical lipid effectscorresponded to the assumed fatty acid content in the cookie, as did theomega index increase.

The 10% improvement of the HdL/LdL ratio was not expected by the fishoil by itself and may reflect the effects of soluble dietary fibers.

In another study, another 20 humans were recruited to consume 1exemplary cookie with high omega-3 fatty acid content per day for 12weeks. The cookie was made according to recipe 1. During the study,omega-3 integration into red blood cell membranes was measured. Theaverage starting value was about 4.3%, and the average value after 12weeks was 8.6, with most of the increase obtained after 6 weeks. It isinteresting to note that 4.3% is also the average value of omega-3integration for Westerners, and 8% is the corresponding value found inthe Japanese population, indicating that eating 1 cookie with highomega-3 fatty acid content per day will bring most Westerner's omega-3levels up to that of a person living in Japan.

1. A method of producing a homogenous food product having a high omega-3fatty acid content, and capable of being cooked without substantialseparation of the omega-3 fatty acid, comprising: combining a fruitjuice concentrate or vegetable juice concentrate with an oil containingan omega-3 fatty acid to form a homogenous liquid mixture, wherein theratio of oil to concentrated juice is approximately 0.5:4-2:1, byweight; and combining the liquid mixture with an additional fiberbinding agent to form an edible food product
 2. The method of claim 1,wherein the ratio of liquid mixture to fiber binding agent is about 1:2,by weight.
 3. The method of claim 1, wherein the ratio of oil toconcentrated juice is approximately 1:1.5-1:2, by weight.
 4. The methodof claim 1, wherein the oil comprises approximately 4-20%, by weight, ofthe total solid food product.
 5. The method of claim 1, wherein theconcentrated fruit juice is concentrated orange juice, concentratedgrapefruit juice, concentrated pineapple juice, concentrated grapejuice, or concentrated cranberry juice.
 6. The method of claim 1,wherein the concentrated vegetable juice is concentrated beet,concentrated tomato, or concentrated carrot juice.
 7. (canceled)
 8. Themethod of claim 1, wherein the oil is a fish oil or vegetable oil. 9-11.(canceled)
 12. The method of claim 1, wherein the oil contains EPAand/or DHA. 13-14. (Canceled)
 15. The method of claim 1, wherein thefiber binding agent comprises a grain selected from the group consistingof cracked wheat, multi-grain, flour, oats, oat bran, oatmeal,pumpernickel, rye, seven bran, twelve bran, seven grain, nine grain,stoned wheat, whole wheat, wheat berry, whole bran, millet, maze,quinoa, rice pectin, fruit peal, and fruit seeds and combinationsthereof.
 16. The method of claim 1, further comprising the step ofadding an additional ingredient.
 17. The method of claim 16, wherein theadditional ingredient is sugar or other natural sweetener, bakingpowder, baking soda, salt, eggs, egg whites, nuts or fruit.
 18. Themethod of claim 16, wherein the additional ingredient is cinnamon,ginger, cloves, nutmeg, or whey.
 19. The method of claim 1, furthercomprising the step of adding water-soluble or oil-soluble dietsupplements or medicaments. 20-21. (canceled)
 22. The method of claim16, further comprising the step of cooking the food product.
 23. A solidfood product produced by the method of claim
 1. 24. The food product ofclaim 23, which is in the form of a cookie.
 25. The food product ofclaim 23, further comprising a water-soluble or oil-soluble medicament.26-27. (canceled)
 28. A manufactured food product comprising about750-4000 mg of non-encapsulated omega-3 fatty acid per about 50-150 gserving.
 29. The manufactured food product of claim 28, wherein theserving size is about 60-100g.
 30. A manufactured food productcomprising about 150-800 mg of non-encapsulated omega-3 fatty acid perabout 15-20 g serving.
 31. The manufactured food product of claim 28 or30, which is in the form of a cookie. 32-42. (canceled)
 43. Amanufactured food product comprising concentrated fruit juice,non-encapsulated fish oil sugar, oats, flour, baking soda, bakingpowder, salt, calcium citrate powder, cinnamon, vanilla extract, and eggwhites, wherein the food product has about 750-4000 mg of omega-3 fattyacid per about 50-150 g serving. 44-47. (canceled)